NCT03257215

Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study

A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Accepted

Summary

Vitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Stoss vitamin D	A single 1.5 mL dose containing 150,000 IU cholecalciferol (100,000 IU/mL) administered on Day 1 (Solution in Olive Oil B.P. )
DRUG	Daily vitamin D	Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
DRUG	Stoss placebo	A single 1.5 mL dose administered on Day 1
DRUG	Daily placebo	A once daily 0.2 mL dose administered from Day 1 to 90

Timeline

• Start date: 2017-10-16
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2017-08-22
• Last updated: 2025-03-14

Locations

1 site across 1 country: Australia